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SPYRAL HTN-OFF MED: Reopens Renal-Denervation Conversation

Following a series of negative trials that seemed to sound its death knell, renal denervation was shown to significantly lower blood pressure in untreated patients with mild to moderate hypertension, in an interim analysis of the SPYRAL HTN-OFF MED study.

Among the first 80 patients, the average 24-hour ambulatory systolic blood-pressure reduction was 5 mm Hg and office systolic blood-pressure reduction was 7.7 mm Hg vs sham control.

The study was not powered for statistical significance but provides biologic proof of principle for the efficacy of renal denervation and will inform the design of a larger pivotal trial.

Investigators eagerly anticipate new guidelines and expect the target blood pressures will be much lower than they"ve been before and a 5-mm-Hg delta from a baseline of 150 to 160 mm Hg will be insufficient.  Whether or not it will be different when it"s partnered with lifestyle changes or concomitant low doses of other medicines, we don"t know.


 1.     Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet 2016; 387: 957−67.